FMF · Class II · 21 CFR 880.5860

FDA Product Code FMF: Syringe, Piston

Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.

These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.

FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Sherwood Medical Co. and Becton, Dickinson and Company.

756
Total
756
Cleared
124d
Avg days
1976
Since
756 devices
265–288 of 756
Cleared Nov 22, 2004
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
K042314
Biogen
General Hospital · 88d
Cleared Oct 28, 2004
1BD SOLOSHOT IX SYRINGE
K042934
Becton, Dickinson & CO
General Hospital · 3d
Cleared Oct 04, 2004
BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
K033589
Micromedics, Inc.
General Hospital · 326d
Cleared Sep 29, 2004
MAGELLAN RATIO DISPENSER KIT
K041830
Medtronic Perfusion Systems
General Hospital · 84d
Cleared Sep 16, 2004
ASPIREX - BONE MARROW ASPIRATE KIT
K041991
Isotis Orthobiologics, Inc.
General Hospital · 55d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Aug 06, 2004
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
K041504
Haemacure Corp.
General Hospital · 60d
Cleared Jul 16, 2004
OPEN BORE SYRINGE
K041344
Isotis NV
General Hospital · 57d
Cleared Jul 15, 2004
CLIP-ON SPACER 20%
K041084
Serono, Inc.
General Hospital · 80d
Cleared Jun 23, 2004
AUTODETECT SYRINGE
K041590
Indigo Orb, Inc.
General Hospital · 9d
Cleared Feb 13, 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721
Vascular Solutions, Inc.
General Hospital · 79d
Cleared Oct 31, 2003
NIPRO DISPOSABLE SYRINGES
K030683
Nipro Medical Corp.
General Hospital · 240d
Cleared Apr 16, 2003
IMBIBE II SYRINGE
K030208
Orthovita, Inc.
General Hospital · 85d
Cleared Mar 11, 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074
Orthovita, Inc.
General Hospital · 176d
Cleared Feb 21, 2003
MERIT MEDICAL 1-ML SYRINGE
K024052
Merit Medical Systems, Inc.
General Hospital · 77d
Cleared Jan 09, 2003
BD INSULIN SYRINGE
K024112
Becton, Dickinson & CO
General Hospital · 27d
Cleared Dec 18, 2002
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271
Terumo Medical Corp.
General Hospital · 78d
Cleared Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088
Wrightmedicaltechnologyinc
General Hospital · 15d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246
Depuyacromed
General Hospital · 21d
Cleared Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
K021071
Biomet, Inc.
General Hospital · 90d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 07, 2002
DUPLOREACH
K014088
Baxter Healthcare Corp
General Hospital · 177d
Cleared Apr 03, 2002
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147
Medtronic Perfusion Systems
General Hospital · 77d
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073
Portex, Inc.
General Hospital · 65d